MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA RM2235

Catalog Number 1492235USUH

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 08/31/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, leica biosystems received a complaint that a user injured their finger during slide preparation and sectioning on their microtome, rm2235.The injured user required medical intervention and visited a hand surgeon to remove non-healing tissue.

Event Description

The leica biosystems manufacturer's investigation revealed the following: the incident was user related because the user disregarded the instrument safety instructions.During the cutting of tissue blocks and preparing of slides, the technician sliced her finger over the free-standing blade.The technician suffered the injury to her finger because she was not wearing safety gloves and had not covered up the blade with the safety guard.The injury was not a result of an instrument malfunction.

• Brand Name: LEICA RM2235
• Type of Device: RM2235
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstrasse 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 12550237
• MDR Text Key: 273989476
• Report Number: 1423337-2021-00012
• Device Sequence Number: 1
• Product Code: IDO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1492235USUH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2022
• Distributor Facility Aware Date: 08/31/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female